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Sign in to claim this brandFOURSTAR GROUP INC.
US
Last updated May 23, 2026
What FOURSTAR GROUP INC. makes
FourStar Group Inc. manufactures personal hygiene and wellness products, including single-use incontinence pants, scented menstrual pads, unscented menstrual tampons, and home-use external massagers. Their portfolio also covers diagnostic tools like immunochromatographic rapid test kits for detecting human chorionic gonadotropin (beta-HCG), as well as intermittent electronic patient thermometers and moist-heat packs for therapeutic use.
The company’s devices are primarily classified as Class I or Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are designed for over-the-counter and home-use applications, with regulatory oversight ensuring compliance with medical device standards in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does FourStar Group Inc. manufacture?
FourStar Group Inc. produces a range of personal hygiene and wellness devices, including single-use incontinence pants, scented menstrual pads, unscented menstrual tampons, and external manual massagers for home use. They also offer diagnostic tools like rapid immunochromatographic test kits for detecting beta-HCG (used in pregnancy testing), intermittent electronic patient thermometers, and moist-heat packs for therapeutic applications. These products are designed for over-the-counter and home-use markets.
Where is FourStar Group Inc. based, and how does that affect its regulatory oversight?
FourStar Group Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the company’s products are classified as Class I or Class II devices, they must comply with FDA requirements for safety, performance, and labeling. The FDA’s Unique Device Identifier (UDI) database includes these devices, ensuring traceability and transparency in the medical device supply chain.
Which regulatory registries list FourStar Group Inc.’s devices, and why is this important?
FourStar Group Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring transparency for healthcare providers, regulators, and patients. Listing in the UDI system helps verify compliance with FDA requirements and supports recall management or post-market surveillance efforts.
How are FourStar Group Inc.’s devices classified under FDA regulations, and what does that mean?
FourStar Group Inc.’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and often require general controls (like good manufacturing practices) for compliance. Class II devices involve moderate risk and may require additional controls, such as performance standards or post-market surveillance. The classification determines the regulatory pathway and oversight level, ensuring appropriate scrutiny based on the device’s intended use and potential risks.
Are FourStar Group Inc.’s devices intended for professional medical use, or are they designed for home or over-the-counter use?
FourStar Group Inc.’s devices are primarily designed for home or over-the-counter use. Examples include external massagers, single-use incontinence pants, menstrual products, and rapid diagnostic test kits like the beta-HCG pregnancy test. These products are engineered for consumer accessibility without requiring professional medical supervision, though they still must meet FDA safety and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 656091279
Catalogue (82)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| B-Pure | 24419586 | FDA UDI | Class I | Active |
| THERA Plus | 64430325A | FDA UDI | Class I | Active |
| Bpure | 64432086A | FDA UDI | Class I | Active |
| b.pure | 64431638A | FDA UDI | Class II | Active |
| B-Pure | 24420202 | FDA UDI | Class I | Active |
| THERA Plus | 64432151A | FDA UDI | Class I | Active |
| Bpure | 64431638E | FDA UDI | Class II | Active |
| b.pure | 64430233EC | FDA UDI | Class I | Active |
| VeriQuick | 11012637 | FDA UDI | Class II | Active |
| Luminant | 11012436DA | FDA UDI | Class I | Active |
| THERAPlus | 11012340F | FDA UDI | Class II | Active |
| B-Pure | 24419988 | FDA UDI | Class I | Active |
| THERA Plus | 64430168BA | FDA UDI | Class I | Active |
| Bpure | 64431641 | FDA UDI | Class I | Active |
| b.pure | 64430233EA | FDA UDI | Class I | Active |
| B-Pure | 24420114 | FDA UDI | Class I | Active |
| VeriQuick | 11012637B | FDA UDI | Class II | Active |
| B-Pure | 24419414B | FDA UDI | Class I | Active |
| VeriQuick | 11012450S | FDA UDI | Class II | Active |
| b.pure | 64431511B | FDA UDI | Class I | Active |
| VeriQuick | 11013002 | FDA UDI | Class I | Active |
| Bpure | 64432086B | FDA UDI | Class I | Active |
| b.pure | 64409515T | FDA UDI | Class I | Active |
| THERA Plus | 64431942AA | FDA UDI | Class II | Active |
| VeriQuick | 11012637M | FDA UDI | Class II | Active |
| VeriQuick | 11013002B | FDA UDI | Class I | Active |
| THERAPlus | 11012340K | FDA UDI | Class II | Active |
| Family Wellness | 0939504 | FDA UDI | Class II | Active |
| B.pure | 64409552P | FDA UDI | Class I | Active |
| b.pure | 64431641 | FDA UDI | Class I | Active |
| THERAPlus | 11012340K | FDA UDI | Class II | Active |
| THERA Plus | 64431942B | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (2)
Establishments registered with the FDA under this company group, matched by name.
- Fourstar Group Inc. TAIPEI · TW FEI 3006078362
- Fourstar Group Kowloon · HK FEI 3007838093